Summary

for people ages 7-85 (full criteria)
at Sacramento, California
study started
completion
Emanual Maverakis, MD

Description

Summary

The primary objectives of this study are to investigate the efficacy and safety of topical steroid ointment (clobetasol 0.05%) for the treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN).

Official Title

A Randomized Placebo Controlled Split-body Double-blind Phase II Clinical Trial to Investigate the Safety and Efficacy of Clobetasol 0.05% Ointment for the Treatment of Toxic Epidermal Necrolysis (TEN)

Details

The experimental focus of this trial is thus to evaluate the safety and clinical outcomes of topical steroid (clobetasol 0.05% ointment) for treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN).

The design of the study is a randomized, placebo-controlled, double-blind split-body Phase II clinical trial in which clobetasol 0.05% or placebo ointment will be topically applied to opposite arms for a period of fourteen days. The primary endpoints of the study are to determine the time to cessation of skin detachment in both groups as well as the safety of topical clobetasol to treat the cutaneous manifestations of TEN. Secondary outcome measures will evaluate efficacy by comparing the time to re-epithelialization and the percentage of affected skin between the clobetasol and placebo arms at various time points.

An additional aim of the study is to characterize the genes expressed during the TEN disease state and any changes in gene expression following treatment with topical steroids, particularly those genes involved in the regulation of programmed cell death (apoptosis). This will be accomplished though molecular analysis of skin biopsy specimens obtained after treatment with clobetasol and placebo ointments. The specific hypothesis being tested is that two weeks of topical clobetasol will promote epidermal keratinocyte survival through suppression of TNF signaling, decreased granulysin expression and inhibition of other pro-apoptotic pathways resulting in shorter disease duration and decreased time to re-epithelialization.

IRB number: 642415-5

Keywords

Toxic Epidermal Necrolysis Stevens-Johnson Syndrome Clobetasol Clobetasol 0.05% ointment

Eligibility

You can join if…

Open to people ages 7-85

  • Characteristic histological findings on diagnostic biopsy
  • Clinical diagnosis verified by two independent physicians
  • Greater than 10% affected body surface area (BSA)
  • Ability to start treatment within seven days or less from the onset of erosions
  • Actively worsening disease (enlarging area of involvement or new erosions occurring over the last 24 hours)
  • Patient Body Surface Area (BSA) > 1.0 m2
  • Reproductive age female patients must have a negative pregnancy test prior to enrollment

You CAN'T join if...

  • Patients will be excluded if they are < 7 or > 85 years of age.
  • Patients who have documented:
  • Uncontrolled infection (e.g. documented bacteremia)
  • Malignancy
  • Known prior immunodeficiency
  • Pregnancy
  • Concurrent use of systemic corticosteroids in the burn center greater than or equal to 0.5 mg/kg/day of prednisone or equivalent dose of similar medication.
  • Greater than 70% eroded skin
  • SCORETEN score >3 on hospital admission
  • Patients will also be excluded if they have: active hepatitis and/or an ALT or AST greater than four times the normal limits, or renal insufficiency with an estimated GFR<50 mL/min/1.73m2.

Location

  • University of California, Davis Department of Dermatology
    Sacramento California 95816 United States

Lead Scientist

  • Emanual Maverakis, MD
    Associate Professor, Dermatology. Authored (or co-authored) 120 research publications

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT02319616
Phase
Phase 1/2
Study Type
Interventional
Last Updated